Kornimate/medical-research-clean huggingface dataset:
effect of preliminary administration of cyclosporine (sandimmun ®) on different markers of cardiac ischaemia induced by cardiopulmonary bypass

Conditions: Coronary Artery Bypass Surgery; Cardiopulmonary Bypass

Summary: observe the effect of preliminary cyclosporine administration on different markers of cardiac ischaemia led by the aortic cross-clamp during coronary artery bypass surgery with cardiopulmonary bypass.

the coronary artery bypass surgery, in spite of substantial improvements during the last years, is still associated to a post-operative mortality and morbidity: myocardial infarction, heart failure, cardiac arrhythmia, renal failure, stroke. these complications are often due to ischaemia - reperfusion injury event. recent studies showed that in case of cellular stress (in particular during the reperfusion after ischaemia) a not specific pore, called mitochondrial permeability transition pore (mptp), could be opened. that caused the loss of ion homeostasis, then cell death as well as by apoptosis as by necrosis. prevent the opening of this mptp during the myocardial reperfusion after coronary bypass, for example, is an important objective to improve the cardioprotection. the cyclosporin a, prevents the mptp from opening. several studies have shown an cytoprotection led by cyclosporin a, after ischaemia reperfusion in several models as isolated rats heart, in vivo rats heart and ex vivo myocardial ( atrial ) human tissues. recently, a multicentric study performed in humans, during the acute phase of myocardial infarction, showed a reduction of infarct size by approximately 40% in the cyclosporine group compared to control group.

Eligibility criteria:
inclusion criteria: * patient hospitalized for a coronary artery bypass surgery * not urgent surgery * left ventricular ejection fraction (lvef)\> 40 % * 18 years and older * patient who have sign the informed consent form * affiliation to the french social security. exclusion criteria: * beating heart surgery with or without cardiopulmonary bypass * patient receiving another surgical gesture combined to the cabg * myocardial infarction or vascular cerebral attack less than 30 days * previous history of cardiac surgery; * renal failure (creatinine \> 200 µmol/l) * uncontrolled hypertension * hyperkaliemy; * hyperuricemy; * acute coronary syndrome * malignant tumor * unchecked infection * previous intravenous administration of sandimmun ®; * allergy to ciclosporin, ethyl alcohol, castor oil or nitrogen * pregnant woman, parturient without contraception, or breast-feeding * age \< 18 years * patient who have not signed the form of consent; * patient under guardianship or being the object of a legal protective measure

Keywords: coronary artery bypass graft surgery (cabg) cardiopulmonary bypass (cpb) cyclosporine ischaemia reperfusion
efficacy and safety of everolimus in patients with metastatic colorectal cancer who have failed prior targeted therapy and chemotherapy

Conditions: Colorectal Cancer

Summary: to assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * patients with metastatic colorectal cancer (crc). * patients must have sufficient and obtainable tumor tissue for biomarker analysis from original surgical resection. * patients with documented disease progression within 6 months of their most recent dose of chemotherapeutic regimens. * patients with at least one measurable lesion. * adequate bone marrow function. * adequate liver function. * adequate renal function. * patients with a life expectancy of \> 3 months. * patients with a world health organization (who) performance status of 0, 1, or 2. * women of childbearing potential must have had a negative serum pregnancy test 72 hours prior to the administration of the first study treatment. * patients who give a written informed consent obtained according to local guidelines. exclusion criteria: * patients currently receiving anti-cancer agents or who have received these within 4 weeks prior to study entry. * patients who have previously received rad001. * patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients. * chronic treatment with steroids or another immunosuppressive agent. * patients with untreated central nervous system (cns) metastases or neurologically unstable cns metastases. * hiv seropositivity. * patients with an active, bleeding diathesis. patients may use enoxaparin. * patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. * patients who have a history of another primary malignancy \< 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix. * female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. * patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to first study treatment. * patients unwilling to or unable to comply with the protocol. other protocol defined inclusion/exclusion criteria may apply

Keywords: colorectal cancer metastatic colorectal adenocarcinoma anti-egfr antibody
internet-delivered psychodynamic therapy for social anxiety disorder (sofia)

Conditions: Social Anxiety Disorder

Summary: the overall aim of this study is to develop and test a psychodynamic internet--delivered psychological treatment for patients with social anxiety disorder and compare its efficacy to a waiting list.

participants with social anxiety disorder (mini telephone interview) will be recruited via mass media and randomly allocated to psychodynamic internet--delivered psychological treatment or to a waiting list control condition.

Eligibility criteria:
inclusion criteria: * social anxiety disorder as diagnosed by the mini diagnostic interview exclusion criteria: * severe depression

Keywords: test psychodynamic internet-delivered psychodynamic treatment patients with social anxiety disorder
predictability of gestational diabetes mellitus in first and second trimester

Conditions: Pregnancy; Gestational Diabetes Mellitus

Summary: the objective of the study is, if an early oral glucose tolerance test combined with maternal history, condition and multiple biomarker analysis can be used to detect gestational diabetes mellitus in the first trimester (12-14 weeks of gestation).

it is the investigators' aim to prospectively examine an extended form of the current 1st trimester screening test for the detection of foetal aneuploidy, in order to ascertain whether this can also be used for the detection of patients at-risk for gestational diabetes mellitus. for this purpose the investigators will include a combination of new markers in a multiplex bio-array manner in conjunction with an early oral glucose tolerance test. a nested case-control proteomic analysis will be performed in a retrospective manner at the completion of this study in order to develop more specific biomarker panels. the primary outcome will be development of gestational diabetes mellitus in the second or third trimester. the secondary endpoints are the delivery outcome, neonatal morbidity, neonatal mortality, maternal morbidity and costs.

Eligibility criteria:
inclusion criteria: * healthy singleton pregnancies * women at least 18 years old and not under guardianship exclusion criteria: * maternal diseases like hypertension, diabetes mellitus and chronic disease, known infection like hepatitis or human immunodeficiency virus * maternal history of hypertensive diseases in previous pregnancy and now under prophylactic acetylsalicylate treatment * foetal genetic, chromosomal or intervention-requiring morphologic abnormalities

Keywords: oral glucose tolerance test fibronectin adiponectin copeptin cortisol
investigator-initiated trial of combined ipilimumab, nivolumab and stereotactic radiation in patients with metastatic clear-cell rcc (ccrcc) who have failed treatment with single-agent nivolumab

Conditions: Clear Cell Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma

Summary: the purpose of this study is to see if continued nivolumab with the addition of ipilimumab plus hypo-fractionated stereotactic radiation (str) of a single lesions results in partial or complete responses in patients with metastatic ccrcc who fail initial treatment with single agent nivolumab.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of metastatic ccrcc. * age 18 years and older * ecog 0-1 * progressive disease after treatment with single-agent nivolumab * life expectancy at least 3 months * presence of measurable disease per recist 1.1 criteria * presence of a metastatic lesion greater than 1 cm in size that is amenable to radiation treatment * adequate organ system function * wocbp and men who are sexually active with wocbp must agree to use appropriate method(s) of contraception. exclusion criteria: * patients are excluded if they have active brain metastases or leptomeningeal metastases (exceptions outlined in the protocol). * active, known or suspected autoimmune disease, such as systemic lupus erythematosus, that require treatment with immune suppressing drugs. note: subjects are permitted to enroll if they have vitiligo, type i diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger * presence of a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration. note: inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * unstable angina or uncontrolled congestive heart failure * uncontrolled hypercalcemia * positive test for hepatitis b virus surface antigen (hbv sag) or hepatitis c virus ribonucleic acid (hcv antibody) indicating acute or chronic infection * known history of testing positive for human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids) * presence of other malignant diseases, except non-melanoma skin care * history of allergy to study drug components. * history of severe hypersensitivity reaction to any monoclonal antibody. * anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days of registration. * women must not be pregnant or breastfeeding. wocbp must have a negative serum pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 7 days prior to registration. * any other medical condition for which treatment with ipilimumab or nivolumab would be medically contraindicated
biological collection for marfan and related syndromes

Conditions: Marfan Syndrome

Summary: the present study will establish a collection of biological samples from marfan patients or with associated diseases to be used for research purposes only, with due respect for confidentiality.

marfan syndrome is an autosomal dominant disease (incidence 1/5000) characterized by ocular, cardiac and skeletal abnormalities. more recently, a decrease in fat and muscle mass has been demonstrated, associated with a decrease in exercise endurance, causing a significant deterioration in the quality of life. little is known about the pathophysiology of these symptoms. patients with marfan syndrome or related diseases are followed at the children's hospital as part of the rare diseases reference centre (crmr) for marfan syndrome at the toulouse university hospital. during regular check-up visits, an extra sample of blood and urine will be collected and stored for research utilisation with the patient's consent. the ultimate objective of this collection is to provide available biological resources to facilitate the development of subsequent studies aimed at better characterizing the multisystemic disorders in marfan syndrome, to understand the pathophysiology of the disease, and to identify biological factors that predict the severity and progression of the disease. the possibility of having systematically collected biological resources will make it possible to answer certain questions more quickly depending on the progress of research.

Eligibility criteria:
inclusion criteria: * children aged at least 3 years old or adult with marfan syndrome or related syndromes * patients affiliated to or beneficiaries of a social security scheme * patients able to receive information on the progress of the study and understand the information form to participate in the study. that implies to master the french language and not to be subject to a restriction of rights by the judicial authorities * patients or legal representative who have given their consent to participate in the study (expression of no objection) exclusion criteria: * patients subject to a legal protection measure (guardianship, curators, or safeguard of justice) * pregnant or breastfeeding women

Keywords: biological collection marfan syndrome marfan associated syndromes
effects of caffeine on intermittent hypoxia in infants born preterm

Conditions: Hypoxia

Summary: the purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (hbo2 sat) below 90%.

infants with prior clinical treatment with caffeine in the neonatal intensive care unit (nicu) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (hbo2 sat) and heart rate will begin as early as 33 weeks postmenstrual age (pma). randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks pma and clinical caffeine has been discontinued for at least 5 days. infants will be randomized to receive caffeine or to continue with usual care. the group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on day #2 and continued daily thereafter until 40 weeks pma. the continuous oximeter recordings will be stopped at the same time. the number of intermittent hypoxia events/hour per week will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.

Eligibility criteria:
inclusion criteria: 1. gestational age of 25 + 0 to 32 + 0 weeks pma at birth, and 34 + 0 to 375 + 6 weeks pma at randomization 2. prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization 3. previously tolerated clinical treatment with caffeine 4. breathing room air (no current supplemental o2 treatment; may have previously required respiratory support) 5. parental consent to enroll in pilot study exclusion criteria: 1. congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome 2. currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy 3. clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped 4. anticipated inability to meet protocol requirements

Keywords: prematurity apnea of prematurity intermittent hypoxia
involvement of extrapancreatic factors on gastrointestinal-mediated glucose disposal

Conditions: Diabetes

Summary: we want to investigate the mechanisms of extrapancreatic effects on gastrointestinal-mediated glucose disposal. in order to do so we will perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions in total pancreatectomised patients and in healthy controls.

in the current project we wish to identify the possible contribution of extrapancreatic effects on gastrointestinal-mediated glucose disposal (gigd). gigd reflects the percentage of an individual's glucose disposal following oral glucose tolerance test (ogtt) which is caused by the oral route of glucose administration. in healthy subjects gigd amounts to \~60%. gigd describes not only the impact of the incretin effect (insulinotropic substances released upon intestinal stimulation) but includes all factors affecting glucose disposal differently during oral vs. iv administration of glucose (including neural reflexes, activation of afferent nerves in the intestinal mucosa, differences in glucagon secretion, hepatic glucose production and first-pass hepatic uptake of glucose, differences in portal and venous blood glucose concentrations and/or at the present unknown factors. it is likely that the incretin effect (pancreatic effect) constitutes a major contributor to gigd, but so far it has been impossible to discriminate between pancreatic and extrapancreatic mechanisms underlying gigd

Eligibility criteria:
inclusion criteria: * pancreatectomized patients * caucasians above 18 years of age who have undergone total pancreatectomy * normal haemoglobin * informed consent healthy subjects * normal fasting plasma glucose (fpg) and normal hba1c (according to the world health organization (who) criteria) * normal haemoglobin * age above 18 years * informed consent exclusion criteria: * pancreatectomized patients * inflammatory bowel disease * operation within the last 3 months * ongoing chemotherapy or chemotherapy within the last 3 months * ostomy * nephropathy (serum creatinine \>150 µm and/or albuminuria) * severe liver disease (serum alanine aminotransferase (alat) and/or serum aspartate aminotransferase (asat) \>3×normal values) * pregnancy and/or breastfeeding * age above 80 years * any condition that the investigator feels would interfere with trial participation healthy subjects * diabetes mellitus (dm) * prediabetes (impaired glucose tolerance and/or impaired fpg) * first degree relatives with dm * inflammatory bowel disease * intestinal resection and/or ostomy * nephropathy (serum creatinine \>150 µm and/or albuminuria * liver disease (alat and/or serum asat \>2×normal values) * pregnancy and/or breastfeeding * age above 80 years * any condition that the investigator feels would interfere with trial participation

Keywords: gastrointestinal-mediated glucose disposal total pancreatectomy incretin hormones glucagon
immunoscore as decision guidance for adjuvant chemotherapy in colon cancer

Conditions: Colon Cancer Stage III

Summary: the overall aim of this study is to prospectively validate the superiority of the immunoscore as a decision guidance for adjuvant chemotherapy in stage iii colon cancer patients, in comparison to the conventional tnm-based high- or low-risk classification.


Eligibility criteria:
inclusion criteria: * 18-75 years of age * all sexes * histologically confirmed stage iii carcinoma of the colon * medical need for an adjuvant chemotherapy * suitable to withstand the course of an adjuvant chemotherapy * written informed consent form (icf) for participation in the study * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * neoadjuvant treatment * metastatic disease * pregnancy, breastfeeding or expectancy to conceive * disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy * uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, qtc prolongation in males \> 450 ms and \> 470 ms in females, participants with history of myocarditis) * hepatitis b or c * human immunodeficiency virus (hiv) * immunodeficiency * allogeneic tissue or solid organ transplantation * systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment * diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers * participants with serious or uncontrolled medical disorders * allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen) * other exclusion criteria: prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness

Keywords: colon cancer immunoscore capox folfox physical exercise
a decision support system for self-management of low back pain - pilotstudy

Conditions: Low Back Pain

Summary: the pilot study precedes a larger randomized controlled trial, to be starting in february 2019. in this pilot study all participants are allocated to the intervention group. the intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain. the plan is presented to the participant in the selfback app.

the selfback intervention consists of the selfback system, that provides the participants with an individually tailored weekly plan of suggested activities to use in their self-management of low back pain. the selfback system constitutes a data-driven predictive decision support system that uses case-based reasoning methodology to capture and reuse participant cases in order to suggest the most suitable self-management plan for participants. the selfback system is an intelligent system that will adjust the suggested self-management plan to the individual participants by using the information available on the participant (baseline questionnaires), weekly self-reported of changes in health status through the app, and data on physical activity via the step-detecting wristband. the weekly plan includes three categories of content; 1) information/education, 2) physical activity monitoring through wearing a step-detecting wristband, and 3) strength and flexibility exercises.

Eligibility criteria:
inclusion criteria: * seeking care from primary health-care practice or a specialised outpatient hospital facility (dk) for non-specific lbp within the past 8 weeks * lbp of any duration * mild-to severe pain-related disability rated as 16 or below on the promis-pf4 function scale. * age: ≥18 years * own and regularly use a smart phone (with at least android 7.0 or ios11.0) with internet access (wi-fi and/or mobile data) * have a working email address and have access to a computer with internet access to complete questionnaires in a web browser. exclusion criteria: * not interested * unable to speak, read or write in the national language (danish/ norwegian) * cognitive impairment or learning disabilities * pathology, such as fracture, cancer, inflammatory diseases, and signs of radiculopathy (severe leg pain, loss of leg strength, or loss of or altered sensation in a myotomal or dermatomal distribution) * serious mental illness, such as major depression, schizophrenia, and psychosis * terminal illness * unable to take part in exercise/physical activity (such as non-ambulatory patients, use of walking aids/assistance, unable to get down and up from the floor independently) * fibromyalgia (diagnosed by a health care professional) * pregnancy * previous back surgery * ongoing participation in other research trials for lbp management

Keywords: digital decision support system app self-management